At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 8 enrolled
Drug / intervention
Spesolimabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment With BI 655130 in Patients With Active Ulcerative Colitis (UC)
In Brief
A Phase 2 clinical trial evaluating Spesolimab for Colitis, Ulcerative. Completed, enrolled 8 participants across 4 sites in 3 countries.
Detailed Summary
The primary objective of this trial is to understand the mechanism of action of BI655130 in patients with UC Secondary objectives are to explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130 treatment
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColitis, Ulcerative
CountriesBelgium, Germany, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartMay 2017
Primary CompletionAug 2019
Study CompletionOct 2019
TodayJul 2026
First PostedApr 4, 2017
Enrollment StartMay 22, 2017
Primary CompletionAug 5, 2019
Study CompletionOct 24, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.2 years ago
Interventions
Spesolimabdrug
12 weeks treatment